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August 2, 2022

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For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

We are pleased to send you our latest edition of the monthly Newsletter which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.

You can access the Newsletter by clicking here. Previous editions can also be found on this page.

EMA communication: Big data use for public health: publication of Big Data Steering Group workplan 2022 - 2025

The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–2025.

The new workplan will allow to further enhance the efficient integration of data analysis into the evaluation of medicinal products by regulators. Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes and facilitating earlier patient access to new treatments.

The former Big Data Task Force carried out a thorough assessment of the challenges and opportunities posed by big data in medicines regulation, which culminated in 2020 in the publication of priority recommendations for regulators on the best approaches to use and generate data. The joint HMA-EMA Big Data Workplan 2022–2025 follows the key recommendations and includes mainly activities related to medicines for human use. However, the scope of some activities covers veterinary aspects, and a separate section in the workplan is fully dedicated to veterinary medicines.

For more details on the workplan’s deliverables and timelines, please click here.

EMA Annual Report 2021

It gives us great pleasure to present to you the European Medicines Agency’s annual report for 2021, which provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU) and highlights EMA’s most significant achievements. These include the Agency’s activities to tackle the COVID-19 pandemic but also its work related to the scientific assessment and supervision of medicines in the EU.

The digital report features main outcomes regarding the evaluation and monitoring of human and veterinary medicines and the European medicines regulatory network’s response to COVID-19, and includes a selection of key figures. It also contains an interactive timeline of important milestones in 2021, allowing readers to explore each topic in more depth through additional documents, audio-visual materials and infographics.

The efficient and timely response to the COVID-19 pandemic remained the number one priority for EMA and the European medicines regulatory network in 2021. EMA recommended four vaccines and five treatments for COVID-19 for marketing authorisation in the EU. The Agency was also successful in supporting the scaling up of vaccine manufacturing capacity that led to a substantial increase in vaccine supply in the EU and globally. In addition, the annual report highlights key lessons learnt during the public health crisis.

In light of the experience accrued by EMA while dealing with the public health crisis, EU institutions took first steps towards extending EMA’s role in crisis preparedness and management of medicinal products and medical devices. In future, EMA will also closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines for the treatment or prevention of diseases causing a public health crisis. An overview of the Agency’s activities to prepare for its new legal mandate is provided in the report.

The report also showcases how EMA continued to address public and animal health needs beyond the pandemic. EMA recommended 92 human medicines for marketing authorisation in 2021. Of these, 54 had a new active substance which had never been authorised in the EU before. This is a 38% increase compared to 2020, by far the highest number in the last five years.

EMA also recommended 12 veterinary medicines for marketing authorisation, including a new vaccine for pigs which has the potential to reduce the need for antimicrobial treatment in animals and could limit the development of antimicrobial resistance (AMR).

Additionally, the report shows how the Agency prepared for the implementation of the Veterinary Medicines Regulation and for the launch of the new Clinical Trials Information System (CTIS) supporting the go-live of the Clinical Trials Regulation, which entered into application in January 2022.

The annual report also draws attention to other major achievements of the Agency, high-impact activities and challenges in 2021. These include efforts to address the public health threat of AMR, activities to reinforce IT security following a cyberattack on EMA in December 2020, as well as digital change initiatives. A number of projects that will strengthen scientific advice for products under development, provide support to marketing authorisation assessments and introduce new data analysis methodologies and tools to strengthen the scientific assessment of medicines are also highlighted in the report.

As in previous editions, the second chapter of the report is dedicated to core statistics and trends illustrating the Agency’s activities in the regulation of medicines. More detailed statistical information about EMA can be found in a traditional print-ready version that is published in a PDF format alongside the digital annual report.

We would like to take this opportunity to thank you for your contributions to EMA’s work. The activities and achievements described in this annual report are built on your scientific expertise and passion for public and animal health that you bring to your work at EMA.

We hope that you find the annual report informative and helpful. If you have any comments or suggestions on the report, especially on the digital version, please take this survey. Your responses are completely anonymous and will help us improve future editions of the report.

*SAVE THE DATE* - 2nd Veterinary Big Data Stakeholder Forum on 23 November 2022

Following the success of last year’s stakeholder forum, we are pleased to announce the 2^nd Veterinary Big Data Stakeholder Forum, scheduled for Wednesday, 23 November 2022.

Driven by the principles embraced by the European Medicines Regulatory Network in the European Veterinary Big Data strategy for 2021-2027, we invite all stakeholders and interested parties to voice their needs, status and expectations in the implementation of advanced digital solution to support key veterinary regulatory activities in areas such as veterinary medicines information dissemination, pharmacovigilance and antimicrobial resistance.

Please block your calendar and express your interest in receiving further updates on this event via Vet-bigdata@ema.europa.eu.

Details on the programme, timing and registration process will be made available in the upcoming weeks.

EMA consultation on two draft veterinary guidelines

The European Medicines Agency has published for public consultation two draft veterinary guidelines:

Draft Guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status)

The objective of this guideline is to elaborate on the scientific criteria within the various provisions of Article 34 of Regulation (EU) 2019/6 and so enable a consistent decision-making process, both for initial marketing authorisation applications as well as for variations to change the prescription status of a veterinary medicinal product.

Concept paper on the revision of the guideline for 4 veterinary medicinal products for zootechnical purposes

The current guideline concerns the documentation to support the safety and efficacy of veterinary medicinal products (VMPs) related to the reproductive system of healthy animals, focussing on food-producing animals. Even though the main focus in the current guideline is on veterinary medicinal products modifying the physiological function of the reproductive system in farm animals, such VMPs are also increasingly used in companion animals.

Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 October 2022.

EMA consultation: Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin

The European Medicines Agency has published for public consultation a draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin.

EMA and the European Food Safety Authority (EFSA) published a report on the development of a harmonised approach to the assessment of the dietary exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal origin. The report is open to public consultation until 31 August 2022.

Veterinary medicines may leave residues in the food deriving from treated animals, and food may also contain residues of feed additives and pesticides to which animals have been exposed to. The presence of residues in food of animal origin is regulated in the European Union to ensure the safety of consumers.

Dietary exposure assessment refers to the process of estimating the exposure to a substance in the relevant human population. Currently, dietary exposure assessments are performed using different legislative/regulatory frameworks, depending on whether the residues stem from veterinary medicines, feed additives or pesticides. While the methodologies are based on common principles, they differ in their scientific approaches, data and practice and can result in different outcomes.

To avoid these inconsistencies, in 2020 the European Commission mandated EMA and EFSA to develop a harmonised approach for consumer exposure.

The report presented is the outcome of the work carried out by an expert group with experts from EMA’s Committee for Veterinary Medicinal Products (CVMP), EFSA, specialists with expertise of Joint FAO / WHO Expert Committee on Food Additives (JECFA) and of Joint Meeting on Pesticide Residues (JMPR) and an observer from the European Chemicals Agency (ECHA).

The group has analysed differences in their respective approaches to the assessment of the exposure of people to residues of veterinary medicines, feed additives and pesticides in food of animal origin. Based on this analysis, EMA and EFSA are proposing a set of recommendations to harmonise and align data gathering and assessment processes to improve consistency of outcomes.

For more related content, please click here.

Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 August 2022.

EMA publication consultation: VICH guidelines: efficacy of anthelmintics: specific recommendations for felines, canines and farm animals

The European Medicines Agency has published for public consultation 9 guidelines by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH):

Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 1 November 2022.

New EMA video on veterinary medicines

We are pleased to inform you that EMA has launched a video to promote the Veterinary Medicines information website.

Launched in January, the website is a one-stop shop for livestock farmers, pet owners and veterinarians to access up-to-date and reliable information on all authorised veterinary medicines in the EU, enabling them to make informed decisions to protect the health of their animals. Thanks to this new platform, everyone can now easily find out where medicines for animals are authorised and available across Europe. The availability of safety information on these medicines is also highlighted with a reference to the veterinary database.

Share, comment or like our posts on LinkedIn and Twitter and on the joint EU agencies Instagram account (one_healthenv_eu).

EMA communication: Start of review concerning veterinary medicines containing the excipient N-methyl pyrrolidone

EMA’s veterinary medicines committee (CVMP) started a procedure for veterinary medicinal products containing N-methyl-pyrrolidone as an excipient.

The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns relating to the appropriateness of user and target animal safety warnings in view of the teratogenic potential of N-methyl-pyrrolidone (NMP).

These medicines have been used widely throughout the EU for decades. It has been noticed that some of the authorised medicines containing the above-mentioned excipient do not have specific safety warnings in the product information to inform about potential risks to the users and target animals. NMP should be considered as a substance which has the potential to cause developmental toxicity and has been legally classified as ‘Repr. 1B (may damage the unborn child)’ according to the harmonised classification and labelling (ATP09) approved by the European Union.

Having considered this issue, the national veterinary medicines regulatory authority of Germany requested CVMP to assess its impact on the benefits and risks of veterinary medicinal products containing N-methyl pyrrolidone.

EMA will now review the available data to determine if any action is necessary to protect animal or public health or the environment.

The Committee invites all stakeholders (e.g. veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure by 13 September 2022 using this form.

For more details on this procedure and related content, please click here.

Start of review concerning veterinary medicines containing procaine benzylpenicillin

EMA has started a review of veterinary medicines containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.

These medicines have been used widely throughout the EU for decades. It has been noticed that the authorised durations of treatment vary between the different products and based on available data not all of them might be appropriate to treat all claimed indications effectively. This could also lead to a risk of development of antimicrobial resistance.

Having considered this issue, the national veterinary medicines regulatory authority of Germany requested EMA’s veterinary medicines committee (CVMP) to assess its impact on the benefits and risks of veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection (link).

In accordance with Article 83(1) of Regulation (EU) 2019/6, all interested parties are invited to submit information relevant to the procedure, addressing the Committee for Veterinary Medicinal Products (CVMP) list of questions by 9 September 2022 using this form.

All documents related to this procedure are available here.

All the latest updates on COVID-19 vaccines and treatments are available by clicking here.

We also take this opportunity to highlight our new webpage on Website outages and upgrades, where you can see when our website will be unavailable and find a list of the main improvements made during previous upgrades.

We are pleased to inform you that the EMA has published its academia collaboration matrix action plan that sets out how the Agency intends to create closer ties with academics and researchers in the next two and a half years.

It lists actions in five areas identified in EMA's Regulatory Science Strategy to 2025:

Regulatory science and partnerships;
Innovation and support to academia;
Communication;
Events strategy;
Trainings.

Highlight actions of 2021:

Development of the EMA Regulatory Science Research Agenda

Consult the action plan:

To learn more about how EMA interacts with academia, please click here.

EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.

The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

“The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” said Emer Cooke, EMA’s Executive Director. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”

The European medicines agencies network strategy to 2025 outlines six priority areas for the network:

the availability and accessibility of medicines;
data analytics, digital tools and digital transformation;
innovation;
antimicrobial resistance and other emerging health threats;
supply chain challenges; and

the sustainability of the network and operational excellence.

The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.

For more details and related content please click here.

The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.

The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with a potential to benefit patients with rare diseases.

Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines.

Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations. These entities should not be financed or managed by private for-profit organisations in the pharmaceutical sector or have concluded any agreement with pharmaceutical companies concerning their sponsorship or participation to a specific research project for which a fee exemption is sought.

Please check the news item on the EMA’s website, or view the dedicated posts on Twitter and LinkedIn for more information regarding the academic fee waiver.

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